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The Wright Total Hip Implant Stems for use with these instruments are indicated for use in total hip arthroplasty for reduction or relief of pain and/or improved hip function in skeletally mature patients with the following conditions:

1. non-inflammatory degenerative joint disease such as osteoarthritis, avascular necrosis, ankylosis, protrusio acetabuli, and painful hip dysplasia;
2. inflammatory degenerative joint disease such as rheumatoid arthritis;
3. correction of functional deformity; and,
4. revision procedures where other treatments or devices have failed
   Modular necks can be used during either cemented or uncemented femoral and acetabular arthroplasty.

The design features of the Anterior Approach Hip Surgery Instruments are summarized below:

• Manufactured from Stainless Steel .
• Modular PROFEMUR® Starter Broach provides means to begin preparation of . proximal femur; overall size envelope is smaller than any existing PROFEMUR® stem, allowing usage with all designs; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
• Modular PROFEMUR® Box Chisel provides means to remove bone in calcar region, . creating opening for other instruments; curvature of lateral surface allows insertion without interfering with greater trochanter; engagement with broach handle allows usage in familiar orientation
• Modular PROFEMUR® Dimple Stem Inserter provides means by which implant may . be impacted via engagement of dimple on lateral shoulder; engagement with broach handle allows usage in familiar orientation
• Modular PROFEMUR® Pocket Stem Inserter provides means by which implant may . be impacted via engagement of modular neck pocket; engagement with broach handle allows usage in familiar orientation
• Lateralizing Rasp provides rigid, aggressively-toothed surface at end of handle that . can be used to contour the proximal region of the femoral canal.
• Dual-Offset Broach Handles Right and Left broach handles provide improved access . to the proximal femur

The provided text describes a 510(k) premarket notification for "Anterior Approach Hip Surgery Instruments." This document focuses on establishing substantial equivalence to predicate devices for surgical instruments, rather than presenting a study proving a device meets specific performance acceptance criteria through quantitative metrics.

Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable or explicitly stated in this type of submission. This 510(k) is for surgical instruments, which are generally subject to different types of evaluation than diagnostic devices or active implants that would have performance metrics like sensitivity, specificity, or object detection accuracy. Without a study detailing specific performance metrics, the other requested information like sample size, ground truth, and expert qualifications are also not provided.

Here's an analysis based on the provided text, indicating where information is present versus not applicable or missing:

Acceptance Criteria and Device Performance Study Analysis

1. A table of acceptance criteria and the reported device performance

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable for this type of submission. This 510(k) does not describe a performance study with a test set in the traditional sense (e.g., for AI/diagnostic devices). The nonclinical testing mentions "Prototypes were used and further evaluated by the design surgeons in a surgical setting," which implies some form of qualitative evaluation but no quantified test set or sample size is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable. No formal "ground truth" establishment from experts for a quantitative test set is described. The "design surgeons" mentioned in the nonclinical testing section serve as evaluators, but their number and specific qualifications beyond being "design surgeons" are not detailed.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. No formal adjudication method is mentioned as there is no specifically defined test set with quantitative endpoints requiring adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• No. This is a submission for surgical instruments, not an AI-assisted diagnostic or decision support device. An MRMC study is not relevant here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• No. This is for physical surgical instruments. There is no algorithm involved.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• Not applicable. For this type of mechanical surgical instrument, "ground truth" typically relates to manufacturing specifications, material properties, and ergonomic/functional performance validated through engineering tests and surgical evaluations. No specific "ground truth" in the context of clinical endpoints (like pathology or outcomes data from a study) is presented. The "evaluation by design surgeons in a surgical setting" acts as a form of qualitative validation against functional expectations.

8. The sample size for the training set

• Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. There is no "training set" or corresponding ground truth establishment process described.

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